Formed in 2002 out of a need for high-caliber consultants within the life sciences industry, Sequence, Inc. is well-known in regulated industries as a commissioning, validation and engineering services provider, specializing in quality and compliance services for software, IT infrastructure, laboratory instruments, analytical methods, equipment, automation, processes, cleaning and utilities, as well as process optimization, laboratory software support, remediation, regulatory compliance services, system/facility startup and much more. All of our work is done in-house with oversight from a management team that cuts its teeth in regulatory compliance.
We are currently seeking multiple Equipment Validation Engineers (Entry, Consultant, and Senior Consultant level) for our Equipment and Utilities Validation Division with an opportunity near Buffalo, New York. Candidates with a willingness to travel up to 75% or more will be given top priority during consideration.
Essential Functions and Responsibilities:
- Create and execute commissioning and qualification protocols/test plans for facilities, utilities, and equipment using a risk-based approach
- Create equipment and process specification documentation
- Conduct field inspections including piping and equipment walk downs, operational startup and troubleshooting
- Track and report on progress to project deliverables, schedules, and budgets
- Develop risk assessment, system impact assessments, and validation plans
- Investigate deviations and write investigation reports
- Review, analyze and interpret system performance data for completed qualification and prepare a final package to summarize data
- A willingness to travel up to 75% or more during or post completion of the initial project span
- Experience or knowledge of sterile or aseptic processing, fill/finish line equipment, commissioning, qualification, and validation
- Ability to communicate effectively at all levels in verbal and written form
- Capability to read and redline equipment P&ID and facility layout drawings
- Knowledge of validation lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc.)
- Working knowledge of Quality by Design (QbD) principles and approach
- Bachelor’s degree in life sciences, engineering or other related technical field (or equivalent experience)
- 2+ years in validation, quality systems, operations or engineering in pharmaceutical or other regulated industry, or applicable recent education
Our consultants must be knowledgeable and willing to go the extra mile in the service of a client, your success is our success. Here are some of the Benefits we offer:
- Competitive Pay
- Medical, Dental, and Vision Insurance
- 401k plan with employer contributions
- Generous PTO/ Time off
- Bonus Plan
- Reimbursable Expenses (Phone, Internet, and Mileage to Client Site)
We value our employees, and beyond the great pay and benefits we offer, we care most about offering opportunity. We are a rapidly growing consulting firm and would love to discuss the prospect of you joining our team. Sequence Inc. is proud to be an Equal Opportunity Employer, M/V/D/F. You will be considered for this position based upon your experience, without regard to race, color, religion, sex, national origin, age, sexual orientation, ancestry; marital, disabled or veteran status. Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Sequence.
Candidates who are currently employed by a client of Sequence or an affiliated Sequence business may not be eligible for consideration.